The Medical Need:
The “Back to Sleep” campaign has been a great success, reducing the number of infant deaths from Sudden Infant Death syndrome (“SIDS) by 25% since its inception in 1992. By one estimate, the risk of death due to SIDS is two times greater while sleeping in a prone position than when the child lies in a supine position. Perhaps then, it not surprising that for infants sleeping in a prone position the death rate declined from 70% in 1992 to 24% in 1996 [National Center for Health Statistics, Center for disease Control and Prevention].
Along with positional advice, the American Academy also recommends avoiding soft and gas trapping surfaces in cribs and eliminating “tummy time” while the infant is awake. Under certain circumstances (such as gastroesophageal reflux, upper respiratory tract obstructions or infectious diseases, etc), a pediatrician may weigh the risks and recommend a prone position. However, one side effect of the “Back to Sleep” campaign has been the marked rise of plagiocephaly, and deformational posterior plagiocephaly in particular [Pollack et al., “Diagnosis and Management of Posterior Plagiocephaly”, Pediatrics, Vol. 99, No. 2, February 1997].
The Problem of Plagiocephaly:
Plagiocephaly typically progresses most in infants ranging between birth and 3-4 months of age. Deformational posterior plagiocephaly is a localized flattening of the cranium, usually near the occiput. This pathological condition is illustrated by FIGS. 1A and 1B respectively.
As seen therein, FIG. 1A provides an overhead view of an infant with deformational plagiocephaly; and FIG. 1B schematically illustrates the positional deformation of the soft infant cranium causing unilateral flattening in the parieto-occipital region, anterior advancement of the ipsilateral ear, and associated anterior displacement of the ipsilateral forehead.
Deformational posterior plagiocephaly occurs most often in infants of four months age or younger because (i) the skulls of young infants are still easily deformed; (ii) the posterior calvaria are rapidly expanding against a flat surface; and (iii) such infants are neuromuscularly immature and lack the coordination to shift their head position. If left uncorrected, the pressure forces will likely remain continuously applied until the infant reaches 6-8 months of age, whereupon the existing deformation will likely become permanent.
Infants with torticollis (wry neck) are particularly at risk for posterior plagiocephaly since their condition will make them favor turning their head one way. By definition, torticollis is a congenital or acquired condition of limited neck motion in which the child will hold the head to one side with the chin pointing to the opposite side; and is the result of the shortening of the sternocleidomastoid (neck) muscle. Thus, as a consequence of the positioning of the head continually in one side position, the infant suffers from the flattening of that side of his head. This asymmetrical plagiocephaly is particularly disfiguring in appearance.
It as been recognized that the vast majority of infants with occipital flattening do not have Craniosynostosis—a premature obliteration of the sutures which results in skull deformity and potential restricted growth of the brain. Also, Lamboid Synostosis, which can mimic deformational posterior plagiocephaly, is remarkably rare, occurring only in an estimated 20 per million live births. Thus, occipital flattening is about 5000-8000 times more likely to occur from a deformation process than from a sutural fusion.
Incidence of Posterior Plagiocephaly:
The incidence rate of posterior plagiocephaly in some infant populations can be as high as 48%. By contrast, the incidence rate of craniosynostosis is only about 1 in 3,000 infants [Bruneteau, R J. & J. B. Mulliken, “Frontal Plagiocephaly: Synostotic, Compensational, Or Deformational”, Plastic and Reconstructive Surgery 89(1):21-31 (January 1992)].
Actual incidence rates vary by patient population and age; and will be influenced by cultural habits for positioning resting newborns. Also, as with all diseases, the severity of the posterior plagiocephaly comes in degrees. Nevertheless, any kind of plagiocephaly is very unnerving for parents to live with.
Research at Children's Hospital and Harvard Medical School in 2002 by Dr. Peitsch and others indicated that 13% of all single-birth newborns and 56% of all twins had localized cranial flattening, a possible precursor to posterior plagiocephaly [Peitsch et al., “Incidence of Cranial Asymmetry in Healthy Newborns”, Pediatrics 110(6):e72 (December 2002)]. A further 10% of all infants suffer from congenital torticollis, which will exacerbate a tendency towards posterior plagiocephaly.
Furthermore, about 25,000 infants are referred to us specialists every year for treatment from plagiocephaly. With 4.6 million live births in the U.S. annually, there are likely to be at least 600,000 infants born each year in need of corrective treatment for plagiocephaly; and prophylactic measures to prevent or avoid deformational posterior plagiocephaly would benefit all newborns.
Conventionally Known and Used Therapeutic Techniques:
As conventional corrective measures, the overwhelming majority of infants with occipital flattening have been treated to date using therapies that redistribute the weight-bearing load on the posterior calvaria. The therapies typically include several different categories or techniques. These include the following general categories:
(A) Simple positioning and re-positioning therapy which encourages parents to shift the infant's sleep position periodically through the sleep periods;
(B) The use of wedge or doughnut shaped support pillows that redirect the pressure of the head in its resting position to the side of the head;
(C) The use of tiltable mattresses or beds that relieve the pressure on the occipital prominence of the head and distribute the pressure over a wider surface area; and
(D) The use of orthoplastic helmets or headbands that apply differential pressure to the head of an infant.
Because plagiocephaly typically progresses most in infants ranging in age from birth to about 4 months, many physicians recommend infant repositioning and observation, presumably because there is hope of spontaneous correction; and because the infant may be viewed as being too underdeveloped for helmet therapy.
Also, anxious parents often purchase off-the-shelf orthotics and wedges in an attempt to prevent further deformation of their baby's head and face. However, most parents report poor results using these modalities; and eventually seek further medical consultation with a specialist. In true fact, there is no clinical data available to date which substantiates the alleged corrective benefits of any commercially sold orthotic, other than the molding helmet.
In addition, while the molding helmet is effective to treat moderate or severe cases of deformational plagiocephaly, such helmets are far too costly and cumbersome for use in minor cases, or as a prophylaxis in high-risk patients (i.e., early plagiocephaly, severe torticollis, premature infants, etc.). Additionally, insurance companies are less inclined to cover the cost of the molding helmet since, in their opinion, such calvarial flattening is considered to be merely “cosmetic”.
Relevant Publications
The published literature provides many descriptive instances for these various approaches. Merely as an aid, a summary of some relevant legal publications includes the following:
Illustrating the use of shaped support pillows for Category B above are: U.S. Pat. Nos. 6,052,849; 6,473,923; 6,564,408; 6,006,381; 6,226,817; 6,460,207; and Published U.S. Patent Applications Nos. 2002/0042954 A1, and 2004/0172762 A1.
Representing the use of tiltable mattresses or beds for Category C above are: U.S. Pat. Nos. 6,421,855; 6,260,553; D448,227; 5,581,832; and Published U.S. Patent Applications Nos. 2003/0033674 A1, 2001/0042269 A1, 2002/0174488 A1, and 2003/0145384 A1.
Exemplifying the use of orthoplastic helmets and headbands for Category D above are: U.S. Pat. Nos. 4,776,324; 6,592,536; 6,266,832; 5,094,229; 5,038,312; 5,915,503; 6,346,353; and Published U.S. Patent Applications Nos. 2003/0195450 A1, and 2004/0015118 A1.
Nevertheless, despite all these developments to date, there remains a recognized and continuing need for further improvements in devices and procedures which can correct and/or prevent deformational posterior plagiocephaly. All such improvements in such singular medical devices and effective treatment techniques would be readily seen as a major contribution and outstanding benefit in this medical field.